TECFIDERA™ has been approved by the U.S. Food and Drug Administration for the treatment of patients with relapsing forms of multiple sclerosis (MS). TECFIDERA™ contains dimethyl fumarate (DMF), which has the following structure:

The starting dose for TECFIDERA™ is 120 mg twice a day orally. After 7 days, the dose is to be increased to the maintenance dose of 240 mg twice a day orally. TECFIDERA™ can be taken with or without food.
There is currently no FDA approved once a day dosing regimen, i.e., QD dosing, for DMF. One objective of the present invention is to develop a formulation (e.g., a unit dosage form) that is suitable for once a day dosing.